Treating Pulmonary Embolism With Laguna Thrombectomy System (TRUST)

Innova Vascular

Status: Enrolling

Conditions: Pulmonary Embolism

Treatments: Device: Laguna Thrombectomy System

Study type: Interventional

Funder types: Industry

Identifiers

NCT06041594

CIP-001 Rev. C

Details and patient eligibility

About

This is a prospective, multi-center, pivotal study to demonstrate the safety and effectiveness of the Laguna Thrombectomy System for the treatment of pulmonary embolism. The Laguna Thrombectomy System is an investigational device which consists of the Laguna Clot Retriever™ System and the Malibu Aspiration Catheter™ System. These devices are manufactured by Innova Vascular, Inc.

Enrollment: 107 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. ≥ 18 years of age; < 85 years old
2. RV/LV ratio > 0.9 as determined by CTA
3. Systolic blood pressure > 90 mmHg
4. Heart rate ≤ 120
5. Patient is deemed eligible for procedure by the interventional investigator
6. CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery)
7. PE Symptom duration ≤ 14 days

Exclusion criteria

1. Systolic pulmonary artery pressure > 70 mmHg on initial invasive hemodynamic assessments
2. Life expectancy of < 90 days in the opinion of investigator at the time of enrollment
3. Subject pregnant or breast feeding
4. Current participation in another drug or medical device treatment study
5. In active chemotherapy or radiation treatment for a malignancy during the course of the study
6. Any intravascular administration of a fibrinolytic agent (such as Alteplase or Tenecteplase) within the last 30 days
7. Presence of recently placed (<8 weeks) intracardiac devices (such as pacemaker leads) in the right ventricle or right atrium
8. History of prior PE within the past 90 days
9. FiO2 Requirement: > 40% (6 LPM) to keep oxygen saturation > 90%
10. Hematocrit: < 28%
11. Platelets: < 100,000/microliter
12. Serum Creatinine: > 2 mg/dL
13. International Normalized Ratio (INR): > 3
14. Major Trauma Injury Severity Score (ISS): > 15
15. Cardiovascular or pulmonary surgery within the last 7 days
16. Known bleeding diathesis or coagulation disorder that cannot be managed with anti-coagulation
17. History of known severe or chronic pulmonary arterial hypertension
18. History or chronic left heart disease with left ventricular ejection fraction < 30%
19. History of underlying lung disease that is oxygen dependent
20. History of chest irradiation
21. Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated
22. Any absolute contraindication to systemic or therapeutic dosage of heparin or anticoagulants
23. Imaging or other evidence that suggests, in the opinion of the investigator, the subject is not appropriate for mechanical thrombectomy intervention (e.g., inability to navigate to target location, predominantly chronic clot or non-clot embolus)
24. Known presence of clot in transit within right atrium or ventricle

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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107 participants in 1 patient group

Laguna Thrombectomy System

Experimental group

Treatment:

Device: Laguna Thrombectomy System